Changing Ways

For many patients across a wide range of therapeutic areas, participation in a clinical trial can provide access to important life-saving medications. However, the efficient conduct of studies has long been complicated by complex protocols, inefficient recruiting methods and logistics that can make participation burdensome, if not impossible. Consequently, numerous trial sponsors, CROs, and clinical services companies are striving to facilitate patient access to studies while also making the trials themselves more patient-centric. In addition to improving recruitment processes and easing the burden of participation, such efforts are largely designed to enhance patient engagement before, during, and after the study.

While the challenges surrounding patient access, retention, and engagement are not new, surmounting these requires new approaches to trial design and administration. Already, some sponsors and CROs are incorporating patient input into study design to align clinical endpoints with patients’ priorities for health outcomes. On the legislative front, citizens and lawmakers in several US states are seeking to pass ‘right to try’ laws intended to enhance access to experimental drugs, especially for terminally ill patients. Nonetheless, such initiatives will not be sufficient unless they are accompanied by efforts that improve the patient experience.

Transportation Resolutions Historically, transportation costs have constituted a very small portion of clinical trial expenses. However, when patients lack reliable transportation, this can lead to noshows and dropouts, which significantly impact study costs and results (1). A National Research Council report identified inadequate transportation as a major contributor to a 30% dropout rate in Phase 3 trials, noting that the problem worsened over the course of lengthy trials (1,2). Factors such as travel distance and intensive trial-related testing schedules are often cited as barriers to participation, especially among patients considered for lengthier trials and the elderly, as well as for those with challenging disease profiles for whom transportation can be very difficult (3).

Kurt Mussina brings more than 25 years of international business success to his role at Frenova Renal Research, including a record of leadership and achievement structuring and orchestrating global business development teams in the CRO industry. As Vice President, General Manager, he is responsible for building organisational alignment of functions to drive profit and research success. Kurt earned a Bachelor of Science in chemistry from Montclair State University, US, and received his MBA from Duke University, Fuqua School of Business, US.

Philadelphia, PA – January 28, 2019. Leading biopharmaceutical services provider PCI Pharma Services (PCI) is pleased to announce the appointment of Angi Calkins as Senior Vice President and Chief Human Resources Officer. Angi joins PCI as the company experiences considerable growth and global expansion, currently with more than 3,500 associates, spanning eight locations comprised of 20 facilities across three continents. PCI features a broad portfolio of outsourced development and commercialization services focused in drug development and manufacturing, clinical trial supply, as well as commercial contract packaging.
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Keeping Abreast of the Competitive Environment in Clinical Development

Thomson Reuters

Strategic management of a therapy area requires hard decisions to be made about which programs to invest in and which to let go. Understanding the rapidly changing competitive environment for your drug candidates is a key input into these decisions. It is easy to lose track of the broader picture when a clinical program is in progress and get blindsided by external events.More info >>

Oxford Global is proud to present for the 14th year our
flagship Biomarkers Congress, taking place 21 – 22 February
2019 in Manchester, UK. An updated programme ensures you will benefit
from talks on the latest strategies and technologies impacting growth in
the biomarker industry.More info >>